First in Human Episode #6 featuring Pravin Dugel

Episode 6 of First in Human features Pravin Dugel, President at Iveric Bio. First In Human is a biotech podcast that interviews industry leaders and investors to learn about their journey to in-human clinical trials. Presented by Vial, a tech-enabled CRO. Episodes launch every Tuesday.

Simon Burns: Pravin, thank you so much for joining us today on First and Human.

Pravin Dugel: Thanks, Simon. Thanks for the opportunity. I’m grateful that, we have this time together.

Simon Burns: Awesome. Well, You’ve been called the best dressed man in retina, so it’s a pleasure. 

Pravin Dugel: Not today. [laughs]

Simon Burns: [laughs] To kick things off, quick introduction. I’m Simon Burns, co founder and CEO of Vial. We are a next generation CRO… faster, better, cheaper, powered by technology is the tagline. Pravin, introduction not necessary, but, tell the audience a little about yourself.

Pravin Dugel: So, I’m a retina physician uh, who’s been an in an academic private practice, for the last 26 years. And currently I’m the president of Iveric Bio.

Simon Burns: Awesome. We saw each other over the weekend. You, and I were both at OIS you led a panel there that included some very controversial comments from a certain Chen at TCV. Who said that if your or Apellis’s commercialization don’t go to, [ [laughs] to, expectations, that it might have a large impact on the retina field. While I’m talking about it, I’m curious just to get your reactions to the comment quite controversial. What did you think?

Pravin Dugel: Yeah, you know, Chen is one of the smartest people that I know.

And I think that was more provocative than anything else. I think, lot of people took that, to the extreme.

I think what he was, look, I don’t want to speak about anybody else. But I think what he was talking about as far as we’re concerned is, when you look at the development of Zimura or ACP as it’s known now… the development has been right down the fairway. It is about as non controversial and straight forward as it can be and about as de-risked as it can be.

When you start out with, for instance, the SPA agreement. From the SPA agreement, when we went to a rolling submission. From that, we went to breakthrough therapy. From breakthrough therapy now, we’ve announced in our 8K that we feel with our interactions with the FDA that the data set the clinical module for GATHER1 and GATHER2 is strong enough to not, even need another trial to go into intermediate AMD. It’s about as de-risked as you can get.

I think we’ve checked all the boxes. if somebody was to say, “Look, what other box is there to check?” There really isn’t another box to check.

And I think his comments, at least as far as it pertained to us, really reflected the fact that look, if you’ve got a company and a product that has done everything possible to de-risk the entire regulatory process one would be really surprised if the regulatory approval didn’t happen on schedule.

I think that was the gist of his comment. I don’t think it was anything more than that, and I think meant really more provocatively than anything else.

Simon Burns: Yeah. First a different topic, congratulations in order for, GATHER2 and ACP a lot of biotech companies are watching you and seeing the, like you said, transition through the clinic. They view it as a success story that they would like to replicate.

What advice do you have for biotech companies looking to, replicate the clinical development operation success of ACP? 

Pravin Dugel: The statistics are really daunting, at least in retina are that if you have a positive phase one result, that’s a positive phase one result, your chance of bringing that drug to market is 11%. I mean, just think about that.

We’re in an extraordinarily risky business, and I’ve been in this business on the other side, for almost three decades. And, if I wasn’t part of many, more failures than successes either I wouldn’t be working hard enough or I would be lying to you.

It’s just the nature of the game and the only thing we have is the data. And I think the job of any team is to make sure that everything possible is done to allow the drug or device the best chance possible of showing itself and whatever it is that shows, whether it be successful, unsuccessful, or indeterminate, is gonna happen. And I think our job is to make sure that there are no questions as to the end result. Indeterminate, obviously, is very difficult. but there’s nothing better than to put together a really clean development program where you have a definitive answer. and I’ve gotta tell you people dwell on successes, and it’s human nature to dwell on successes. But really, what advances this field as much as successes, are failures.

and we learn from failures a great deal. And I know I have throughout my career and simply because I’ve been part of many, more failures than successes and the failures teach us.

In one of the meetings, not long ago, I was asked to share a panel. And they said, “Pick your topic,” and my topic, which is something that I’ve wanted to do for a very long time, was what have we learned from [00:05:00] unsuccessful clinical trials.

And I think there’s a great deal that we owe to people that have conducted clinical trials extremely well, although the results have been unsuccessful. We stand on the shoulders of people before us, right? Because of what they have done and what they’ve shown us, the data that we’ve seen, that has propelled us to doing another trial. I really feel that we don’t have any control over whether something is successful or not. But we do have control over whether we conduct ourselves properly or not.

Simon Burns: I’d like to go one click deeper there. The lessons from the trial failures, nitty gritty tactical device on clinical development, clinical operations, how do you oversee the CRO? How do you pick a CRO? what advice do you have, in terms of those tactical decisions that you- you’ve learned through, failure?

Pravin Dugel: Those parts are actually quite easy, I’ll be honest with you we all know, who the good people are that we can work with, externally. We all know how we can get great people to be hired internally and I’m extremely proud of the team that we have. I mean, I think we’ve got… obviously I’m very biased. the best retina team there is. I- I couldn’t be prouder of our team. The really, more difficult thing, which is, something that I think is very much underrated is how you communicate and how you maintain your integrity.

Because when you develop something, it’s really never a linear process. There are always ups and downs, and if you have competitors, there’s always a correspondence that happens with the competitors. And how you conduct yourself both internally and externally, with passion with great deal of energy, with commitment… but most importantly, with integrity that’s supported by data. That’s really the most important part.

Who you hire and all that, I mean, that’s a logistical thing. And that’s fairly easy. Now how you handle yourself when the data is not what you expected it to be, or when there are nuances. Or whether there issues out there that you have no control over that may affect you negatively, and how you communicate that internally, how you communicate that externally.

I think that’s what separates a good company from a great company. 

Simon Burns: Let’s talk more about your team. I think what you said is probably right that one of the best teams in retina, and I think that comes across. PI has mentioned it to us. Wallstreet certainly mentions it.

What advice do you have with building a team that’s kind of best in class, like yours? 

Pravin Dugel: I think having an identity, right? And I think a lot of people try to do too many things. And that’s the temptation is to go out and try and do a whole bunch of things. I think there are not very many people that really look inward and say, “Look. We can’t do everything. We can’t even do this much. But what we want to do, is we want to do a few things, and we want to do it, as well as we possibly can.”

I mean, I go back to the advice that my dad gave me, when I was very young. He said, “You can be whatever you want to be. But whatever it is that you’re gonna be, be the best that you possibly can.”

And it’s the same thing. It sounds very trite, but that’s really true. And in this company, for instance this, was a gene therapy company. And the GATHER1 trial was successful. It was very tempting to keep everything and develop everything have this big pipeline.

At a certain point, I think the, correct decision was made, which we announced publicly. That, look, we are going to be focused on a winning horse. And our company is simply not big enough and doesn’t have the resources to go ahead and develop all these other, wonderful things that are in our pipeline.

And so, the strategic decision we made was to say we’re a company that’s made retina for retina. And at this point, the asset that we have… again, remember 11% chance, is Zimura.

And what we’re gonna do, is we’re gonna go ahead and do whatever we can to develop Zimura to its best potential that we can get. And to do that, what we need to do is to divest ourselves, at least out license these gene therapy products, because they need to go to patients, but we’re not… the people at this point that have the resources to do that.

it’s kind of like having a great pizza shop And really good ice cream in the back, You know what I mean? It’s like, one or the other.

So I think that was the correct decision. And now we’re at a point where we’re big enough that it’s very tempting to go to meetings like, where we just met in OIS, and say, “Wow, there’s all this fantastic…” and there is by the way, “great innovative technology. And why don’t we just go on a shopping spree?” And this and that’s the temptation. And, we’re not gonna fall into that.

Look, we are gonna be a retina company. We are a retina company. We’re here to stay. But we’re gonna go ahead and go in a very, disciplined, strategic manner where we grow and make one success lead to another.

We don’t want to be in a situation where we fall into the temptation of simply, getting things or trying to do things that we’re not good at. Everything that we do, we want to make sure that we’re excellent at.

Simon Burns: You’ve successfully closed two fundraisings in this bear market. Not an easy feat at all. Have you learned raising money in this type of environment? And what advice do you have for biotech companies looking to do the same?

Pravin Dugel: Again, it really goes back to what I said earlier on, which is, keeping the integrity of the company and your communication. and it doesn’t happen overnight. Look, I joined this company, we were running out of money, and we were trading below two, I think it was. And, we had the overhang of a failure and that was [00:10:00] Fovista. 

And when I joined, it’s not that we started out on level ground, we started underground. Right? And we together a great team. There are a group of people here that- are fantastic. Our CEO, Glenn Sblendorio, has been a leader in, making sure that the company continues to grow. There are people here that have been here like Keith Westby and others for a long time that have never lost the faith.

And then we integrated new, great people that- came in after that. Our Chief Commercial Officer, Chris Simms. Um, our Chief Development Officer, Dhaval Desai. Our regulatory head, Sneh Shah.

 All of these people come in, and they will, work together and organically row towards in the same direction. And if you can make that, and if you can show people that you can execute, it takes time, right? It’s not something that’s just gonna light up overnight it takes time. But if you can go ahead and show that and keep on communicating to people that, look, you can execute, and your data is there. And you can communicate in an honest fashion, even when things may not be quite the way you want it to be.

I think it’ll eventually reward itself. And I think that’s what happened with this raise. Every raise, has been better than the raise before. In this case, we started out trying to, get $175 million. Which is a big amount. We were oversubscribed eight times, which is pretty remarkable in this environment. Eight times.

And the discount that we gave was less than 5%, which is also quite remarkable. We ended up taking upward of 300 million. But I think that was not a result of just this round that was a result of how we communicated and how we have executed for the last few years.

Simon Burns: You ended your panel over the weekend asking the panelist about ophthalmology in two years time? 

What is the industry gonna look like in two years time? I’m throwing this back at you, Pravin. What does the ophthalmology space look like in- two years? What are you excited about?

Pravin Dugel: Yeah, I love those questions, and everybody asks them. But you know, people gave all kinds of answers, Simon, as you remember, right? this is what’s gonna happen to D- DME, this is what’s gonna happen to GA.

the best answer was the simplest answer that Paul Bresge gave, if you remember that. He said, “We’re gonna make some blind people see.”

Simon Burns: Yeah.

Pravin Dugel: and I guess I would add to that and say, we’re gonna make some people that would otherwise go blind, keep their vision. Right? And if we can do that, my God, what an achievement. And we’ve already been doing that.

I can see personally… look, I have a family history of macular degeneration. My father lost one eye. He’s 91 years old. He lost one eye, because of what macular degeneration… he’s been getting Lucentis, for the last 20 years in his only eye.

We’re already doing that, and if we can have more people who can either have their blindness cured or keep their vision, however it is… with the great innovations that we have. Not just in retina, but in cornea, and glaucoma, and neuro protection.

The amount of innovation that, we saw this weekend, Simon, you and I in this meeting is unbelievable. Right? Even when we’re in the worst of markets, to see people get up there and say, “Look. I made this machine, in my garage.” Or “I spent my life savings innovating this drug.”

That’s really what drives this industry. And I’m, so admire those people that have these ideas and have the passion to do that, and that’s what keeps us going.

That’s what I look forward to in the next two years.

Simon Burns: Absolutely. Truly remarkable.

With that, Pravin, thank you for joining us. I appreciate the time, and, thank you for the conversation.Pravin Dugel: Simon, thank you. I’m very grateful to you for having me, I really enjoyed the conversation. Thank you.

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